IDB-011 Safety Study

Overseen By Main Contact

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: IDBiologics, Inc.

Disqualifiers: RVFV infection, Malignancy, Cardiovascular, HIV, others

Compensation: Varies

Number of Visits: 4

Duration: 4 days

40 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since the trial is for healthy participants and has strict eligibility criteria, it's possible that you may need to pause certain medications. Please consult with the trial coordinators for specific guidance.

What safety data exists for IDB-011 or similar treatments?

The MetaADEDB 2.0 database provides comprehensive information on adverse drug events, which can be useful for assessing the safety of treatments like IDB-011. Additionally, safety data from clinical trials often include reports of adverse events, and many trials continue without significant safety issues. It's important to review detailed safety information and adverse event reports when considering participation in a clinical trial. ^{1 2 3 4 5}

What is the purpose of this trial?

Phase 1 randomized, double-blind, placebo-controlled trial to evaluate safety, tolerability, pharmacokinetics (PK) and immunogenicity of IDB-011 following intramuscular (IM )administration of single ascending doses to healthy adult participants.

Eligibility Criteria

This trial is for healthy adults who can participate in a study testing the safety of different doses of IDB-011, a potential treatment for infections like Coccidioidomycosis and Rift Valley Fever. Specific eligibility criteria are not provided.

Inclusion Criteria

I am a healthy male or female.

Agree to not donate blood or plasma during study participation

Body mass index (BMI) within 18.0 kg/m2 to 30.0 kg/m^2, inclusively

Exclusion Criteria

History of hypersensitivity reaction

I haven't received any vaccines in the last 28 days.

I have had a Rift Valley fever virus infection before.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive single ascending doses of IDB-011 or placebo via intramuscular injections

4 days

In-patient stay for up to 4 consecutive days

Follow-up

Participants are monitored for safety, pharmacokinetics, and immunogenicity

1 year

Treatment Details

Interventions

• IDB-011

Trial Overview The trial is assessing various dose levels (1 to 5) of IDB-011 compared to a placebo. It's designed as a Phase 1 study where participants receive one-time intramuscular injections in increasing amounts to evaluate how safe it is and how the body processes it.

Participant Groups

Group I: Experimental: IDB-011 Cohort 5 Experimental Treatment 1 Intervention

IDB-011 dose level 5

Group II: Experimental: IDB-011 Cohort 4 Experimental Treatment 1 Intervention

IDB-011 dose level 4

Group III: Experimental: IDB-011 Cohort 3 Experimental Treatment 1 Intervention

IDB-011 dose level 3

Group IV: Experimental: IDB-011 Cohort 2 Experimental Treatment 1 Intervention

IDB-011 dose level 2

Group V: Experimental: IDB-011 Cohort 1 Experimental Treatment 1 Intervention

IDB-011 dose level 1

Group VI: Comparator: Placebo Placebo Group 1 Intervention

Normal saline

Who Is Running the Clinical Trial?

IDBiologics, Inc.

Lead Sponsor

Joint Program Executive Office Chemical, Biological, Radiological, and Nuclear Defense Enabling Biotechnologies

Collaborator

Trials

3

Recruited

1,000+

Findings from Research

MetaADEDB 2.0 is an updated online database that now includes 744,709 drug-adverse drug event (ADE) associations, representing a 40% increase from its previous version, making it a more comprehensive resource for researchers.

The new version features a user-friendly web interface, enhancing accessibility for drug safety assessments and studies in drug discovery and development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MetaADEDB 2.0: a comprehensive database on adverse drug events. Yu, Z., Wu, Z., Li, W., et al.[2021]

The safety of marketed drugs is a significant concern, as some commonly prescribed medications can lead to serious or life-threatening side effects in patients.

The ChEMBL resource will provide a curated drug safety data set, including toxicity classifications and black box warnings, which will be freely available and regularly updated to aid in drug safety research and discovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drug Safety Data Curation and Modeling in ChEMBL: Boxed Warnings and Withdrawn Drugs. Hunter, FMI., Bento, AP., Bosc, N., et al.[2023]

The DIMDI provides comprehensive databases that contain valuable information on adverse drug reactions, which can help healthcare professionals and researchers understand the safety profiles of various medications.

Access to these databases is crucial for monitoring drug safety and improving patient care by identifying potential risks associated with drug treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Information on adverse drug reactions in databases hosted at the German Institute of Medical Documentation and Information (DIMDI)]. Bystrich, E.[2016]

The recent fatal adverse event in the BIA-102474-101 clinical trial highlights significant limitations in the current safety review process for first-into-human trials, despite previous trials with similar compounds being conducted without incident.

To improve safety in future trials, it is crucial to implement sequential dosing strategies, thorough reviews of preclinical toxicity studies, and systematic risk assessments, especially for novel compounds that may pose higher risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implications of the BIA-102474-101 study for review of first-into-human clinical trials. Eddleston, M., Cohen, AF., Webb, DJ.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

MetaADEDB 2.0: a comprehensive database on adverse drug events. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Drug Safety Data Curation and Modeling in ChEMBL: Boxed Warnings and Withdrawn Drugs. [2023]

3. Germany pubmed.ncbi.nlm.nih.gov

[Information on adverse drug reactions in databases hosted at the German Institute of Medical Documentation and Information (DIMDI)]. [2016]

4. Japan pubmed.ncbi.nlm.nih.gov

Analysis of information submitted by clinical trial sponsors regarding the safety of investigational drugs. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Implications of the BIA-102474-101 study for review of first-into-human clinical trials. [2021]